Mallinckrodt to sell pioneering echo contrast agent
four years of premarket approval (PMA) review, the Food and Drug
Administration this month certified the first ultrasound contrast
agent for sale in the U.S. Echocardiography agent Albunex, developed
and manufactured by Molecular Biosystems (MBI) of San Diego, will
be sold exclusively in North and South America by medical imaging
contrast supplier Mallinckrodt Medical of St. Louis.
The success of Albunex in penetrating the echocardiography
market will be closely watched as an indicator of the future potential
of the ultrasound contrast market. The U.S. market potential of
Albunex is fairly limited, however, relative to the universe of
ultrasound exams performed in all applications. About 10 million
echocardiograms are performed annually in the U.S. Albunex may
reach 10% to 20% of that segment, according to Richard M. Stern,
vice president of marketing for MBI.
The market for Albunex in the U.S. could amount to about $150
million annually, estimated Daniel P. Moynihan, echocardiography
marketing manager for Mallinckrodt. The size of the ultrasound
contrast market will grow dramatically as new agents come on-line.
"The whole ultrasound contrast market will be huge when
newer agents are developed, such as ones that will (image) myocardial
perfusion," Moynihan said. "This agent is our first
step into the field of ultrasound contrast. We feel this will
be a growing and important field since it will bring additional
information to physicians at a lower cost (than other imaging
Eventually, contrast echocardiography could help reduce the
number of more expensive medical procedures required, such as
cardiac catheterization or angioplasty, he said.
Albunex consists of air-filled albumin microspheres, which
reflect ultrasound signals. The agent is indicated by the FDA
for use in enhancing opacification of the heart's left ventricle,
Stern said. This function improves the cardiologist's ability
to resolve the endocardial border. It is necessary to see the
border when measuring wall thickness and determining regional
Mallinckrodt is responsible for developing general radiology
applications for Albunex. The agent has shown potential in indicating
fallopian tube patency. Breast imaging could be another application,
Sales of Albunex will start gradually, he said, as cardiologists
learn about not only a new type of contrast medium but an entirely
new procedure -- contrast echocardiography.
Mallinckrodt plans a targeted launch of the product, placing
it first with a select group of physicians and hospitals. The
company expects that this introduction will help educate echocardiography
users, including physicians and sonographers, about the new technique,
and will better determine the agent's efficacy and ease of use,
The commercial launch of Albunex in the U.S. could be hampered
by a lack of reimbursement for contrast echocardiography. Procedural
data must be gathered and presented to the American Medical Association
to facilitate creation of a current procedural terminology (CPT)
code for contrast echocardiography. CPT codes are required for
both Medicare and private insurance reimbursement of a medical
procedure, Stern said.
Insurance payments for Albunex may be attained using related
CPT supply codes for echocardiography, such as the code specifying
intravenous administration for stress echo studies, he said. Some
direct billing of users for the contrast agent is also expected.
Mallinckrodt is formulating a reimbursement strategy for Albunex
in the U.S.
While a price has not yet been determined for Albunex in the
U.S., it is likely that the ratio of contrast to ultrasound exam
cost will be more favorable in this market than in Japan, where
the agent has been selling since January for $75 per 5-mL vial,
Stern said. Two to three vials are used for a single procedure.
"We feel that, in the U.S., the price of contrast media
will not be as high as the cost of the procedure, assuming $100
to $150 for contrast, which is comparable to Japan," he told
SCAN. "There is a big difference between the cost of an ultrasound
procedure in Japan and the cost in the United States. An echo
in Japan is about $100. An echo in the U.S. is in the $300 to
Slow growth in Japan. Albunex was approved for market in Japan
last year (SCAN 10/6/93). MBI's Japanese licensee, Shionogi &
Co., did not initiate sales until a National Health Insurance
price was established by the Chuikyo, Japan's Central Social Insurance
Japanese sales of Albunex have been growing steadily but at
a slower pace than anticipated, Stern said. Part of the reason
may be the agent's high price relative to the cost of ultrasound
imaging in that market.
Hafslund Nycomed, MBI's licensee for Albunex in Europe, has
not yet initiated sales in that region, although national approval
was received in two markets: Sweden last year and the U.K. shortly
following the FDA announcement. Nycomed's strategy is to get approval
in the larger markets of Germany, France and Italy before launch
of the product, he said.
The Norwegian contrast supplier, which purchased Sterling Winthrop's
medical imaging business last June (SCAN 7/13/94), will use its
U.K. approval to approach the European Union with a multistate
submission for Albunex, Stern said.
Reflecting the close-knit nature of the world contrast media
market, MBI's other European licensee -- for its not-yet-approved
gastrointestinal ultrasound agent Oralex -- is Bracco of Italy.
Bracco purchased Squibb Diagnostics last month. The Italian firm
has indicated a desire to withdraw from the Oralex licensing agreement,
however, and the two partners are negotiating the matter,he said.
Bracco picked up SonoRx, another GI ultrasound agent under development,
with the Squibb deal (SCAN 8/10/94).
Albunex is the first approved transpulmonary agent able to
image the left ventricle, which cardiologists prefer to the right
ventricle, he said. The left side of the heart pumps blood to
the body and is the location of most cardiac problems.
Schering's Echovist ultrasound cardiac agent, which is approved
in some markets worldwide, is a right-heart agent. This factor
may have limited demand for the product, Stern said. The German
company has a second left-heart agent under development called
Levovist, which is farther back in the R&D pipeline. Both
Schering agents are based on sugar molecules. Levovist uses a
stabilizer to achieve transpulmonary passage.
While clinical investigation has shown that Albunex can image
blood flow, MBI is not making this claim. The company has a second
cardiac ultrasound agent, FS069, under development, which will
image myocardial perfusion, Stern said. The company has not yet
revealed the nature of this agent.
"Certainly, the goal of contrast echocardiography is to
have an agent that flows through the myocardial tissue, representing
an indicator of myocardial viability," he said.
Results of animal testing of FS069 showed it was able to view
myocardial perfusion in almost 100% of the experiments, Stern
said. The agent also has potential to visualize kidney, liver
and testicular perfusion. MBI is preparing to file with the FDA
for approval to begin clinical trials with that agent.
It is hoped that by the time Albunex's competitors make it
though the FDA, MBI will be ready for market with its next- generation
technology, he said.